As of 2023, Scientific and Medical Affairs Consulting, LLC (SMAC) continues to provide exceptional scientific expertise to support drug development from pre-IND (Investigational New Drug) through commercialization. With a wealth of experience, SMAC has been a trusted partner for over 35 biotechnology and pharmaceutical companies, assisting them in navigating the challenges and dynamic landscape of various therapeutic areas.
SMAC's dedicated and diverse team possesses a range of complementary skill sets, allowing them to effectively address each client's unique challenges with precision and efficiency. By leveraging our in-depth knowledge and understanding of the industry, SMAC offers tailored solutions to support our clients' drug development efforts.
From early-stage research to regulatory submissions and commercialization strategies, SMAC collaborates closely with their clients to provide comprehensive scientific and medical affairs support.
By partnering with SMAC, biotechnology and pharmaceutical companies gain access to a team of seasoned professionals who are well-versed in the latest scientific advancements and regulatory requirements. With a focus on optimum speed, quality, and expertise, SMAC strives to accelerate the development of innovative therapies and contribute to the improvement of patient outcomes.
Judith Steenbergen, PhD
President and Founder
Judith is an accomplished pharmaceutical executive with 20 years of experience in biotechnology and small pharmaceutical companies in pre-commercial and commercial settings. She has a strong background in scientific and medical affairs, with expertise in drug development, medical strategy, post-approval research, stakeholder engagement, and tactical execution.
As President and Founder of Scientific and Medical Affairs Consulting, LLC, she provides strategic scientific and medical affairs consulting to small biotechnology companies. She specializes in global scientific strategies, including scientific platform development, publication planning, data gap analysis, and lexicon development. She supports small companies in drug development by providing assistance in data gap analysis, IND/NDA writing, FDA advisory committee preparation, and label negotiations. She leads the strategic and operational activities of the organization.
Throughout her career, she has demonstrated a track record of successes in early and late-stage drug development. She is passionate about being a strategic thought partner with internal and external stakeholders and elevating the value of medical affairs using data-driven scientific strategies.
Judith received her B.A. in both Microbiology and Chemistry at Miami University (Oxford, OH) and her Ph.D. in Microbiology and Immunology at Albert Einstein College of Medicine (Bronx, NY). She spent over 20 years supporting antibiotic development programs at small biotechnology companies including Cubist Pharmaceuticals and Paratek Pharmaceuticals.
Hina Patel, PharmD, BCPSExecutive
Hina is a director level Medical Affairs manager with over 15 years of experience in the pharmaceutical industry. As a Clinical Scientific Director with primary responsibilities of interfacing with external customers both nationally and internationally. Her experience has included working with Business Development on evaluating potential assets, working with Government Affairs on potential legislation, building out a strategy for global expansion of a company, and assisting on the build out of Medical Affairs functions from the ground up with a focus on strategic imperatives and differentiation.
As Executive Vice-President of SMAC, she focuses on strategic planning for small Biotechnology companies to help align the key stakeholders within a company. Utilizing her scientific and medical affairs expertise, she specializes in global scientific strategies, including scientific platform development, publication planning, data gap analysis, and lexicon development.
Hina earned her PharmD at the University of North Carolina at Chapel Hill School of Pharmacy. She also completed a pharmacy practice residency at the University of Virginia Health Sciences in Charlottesville, VA. Hina spent 9 years in clinical practice primarily as a Critical Care Pharmacist (Medical Intensive Care Unit) at Emory Healthcare prior to her experience in the pharmaceutical industry. Her 13 years in the industry have all been in the infectious diseases space with experience at Cubist/Merck Pharmaceuticals, Tetraphase Pharmaceuticals, and most recently, Achaogen, Inc. She has several publications in peer-reviewed journals and authored a book chapter in Rau’s Respiratory Care Pharmacology.
Rolf Wagenaar has over 25 years of marketing, sales, and management experience.
Most recently as Executive Director and Brand Leader of an antibiotic portfolio at Allergan/AbbVie. Prior to joining AbbVie, he successfully led the commercial efforts for cefepime since launch and aztreonam with Élan Pharmaceuticals.
He has extensive launch experience with 8 anti-infective product (re)launches in the US. Rolf has strong relationships within the infectious disease community and is a member of the Society of Infectious Disease Pharmacist (SIDP) and the Surgical Infection Society (SIS). During his career he has moderated over 75 scientific advisory boards, is actively involved in early-stage clinical trial planning, business development, lifecycle strategy, and post marketing strategic data generation.
Rolf has been an invited speaker and panelist at scientific meetings such as ECSMID/ASM, AMR World Conference and BIO and authored several articles on antibiotic development. Growing up in The Netherlands, he holds a BS and advanced teaching degree from The Hague University of Applied Sciences.
Director of Operations & Program Management
Noah has thirteen years of experience across both academia and industry. He cut his teeth in Clinical Operations for both an academic site and sponsors, and has worked in Medical Affairs for the last eight years at small to medium sized pharmaceutical companies. His focus is building Medical Affairs teams for early stage infectious disease, rare hematology, oncology and other rare disease focused companies. This includes helping new organizations build out the infrastructure necessary for pre/peri/post-launch success. With a deep background in IT, he has worked closely with leadership to come up with right-sized systems and solutions for field, medical information, scientific communications and HEOR. He has helped multiple teams roll out and manage solutions like Medical Legal Review Committees, CRMs, Medical Information Call Centers, publications/citation management and library services.
He also works with Medical Affairs teams to develop medical plans, create KOL segmentation/engagement plans, provide lifecycle project management, and right size standard operating procedures and business practices. This also includes creating a congress strategy and providing both high level strategic guidance and day to day operational support.
Noah holds a Bachelors from Pitzer College and has worked for University of California San Francisco’s Solid Tumor Phase 1 clinic, Genentech, Achaogen, Atara Biotherapeutics, Foundation Medicine and Forma Therapeutics before joining SMAC.
Shelley Campeau, PhD, D(ABMM)
Shelley is a highly qualified board-certified medical microbiologist with extensive experience in both clinical and public health microbiology. Over the past four years, she has been employed at an in vitro diagnostics (IVD) company, where she has played a crucial role in various aspects of clinical trials, FDA-regulated studies, and product development.
As a Principal Investigator and Study Coordinator, Shelley has successfully managed FDA-regulated pre-clinical and clinical studies. She has been involved in the development and review of pre-submissions, protocols, and clinical reports, ensuring compliance with regulatory requirements. Shelley's involvement in diagnostic development has allowed her to collaborate extensively with research and development, strategic marketing, and regulatory departments. Her deep understanding of clinical microbiology has been instrumental in providing key insights for company products. She has led over 20 studies, including both sponsor- and investigator-initiated projects, while also engaging in numerous projects with the Clinical Laboratory Standards Institute (CLSI).
Shelley's educational background includes a PhD from the University of Irvine, followed by a 2-year Medical and Public Health Microbiology Postdoctoral Fellowship at UCLA. During her fellowship, she received comprehensive training in various areas of clinical microbiology, including virology, bacteriology, antimicrobial susceptibility testing (AST), and molecular diagnostics.
Michael Goodman, MD
Mike is a Physician and Medical Affairs consultant with extensive experience in oncology and imaging sciences. As part of his research activities, he was involved in clinical applications research involving PET/MRI neuroimaging for glioblastoma, lymphoma, and CNS infections. Recently, he was involved in the study design and protocoling of several oncology projects which utilized next-generation sequencing of circulating tumor DNA with novel imaging applications. As part of this work he is in regular communication with key opinion and thought leaders in order to identify clinical gaps where emerging technology can fill important needs.
Working with Scientific and Medical Affairs Consulting, LLC, he is deeply involved in the longitudinal work required for early-stage companies, from fundamental scientific platform development through study design, publications, and regulatory submissions. Mike received his undergraduate degree from the University of Rochester and his Doctor of Medicine from Stony Brook University School of Medicine. He began his clinical training in general surgery before leaving to work with an early-stage artificial intelligence imaging software company and beginning his work in medical and clinical affairs. During his time in medical school and residency, he was deeply involved in medical student education and received awards both in medical school and residency for his exceptional contributions to medical education.
Amira Bhalodi, PharmD
Amira has worked within the anti-infective pharmaceutical industry and most recently for
in vitro diagnostics within clinical microbiology. She has experience interfacing with multiple cross functional teams, such as R&D on relevant future improvements and new assays, as well
as field-based teams to support clinical and laboratory implementation.
She worked to help develop research strategies to support evidence generation plans with respect to clinical outcomes and various clinical microbiology projects. She completed her postgraduate training (PGY-1 Pharmacy residency) at the Philadelphia VA & PK/PD Fellowship at the Center for Anti-Infective Research & Development.
Esther is responsible for business operations, contract administration and personnel management at SMAC. She strives to keep the business productive, efficient and organized at all times. She has been the Business Manager at Scientific and Medical Affairs Consulting (SMAC) for the last 4 years.
Prior to her role as business manager for SMAC she spent 7 years as the assistant to the president of a manufacturing company in PA. Her position required her to collaborate with both staff and management and offer solutions to problems with a high level of professionalism and confidentiality. She also honed her skills as a motivator and positive morale creator for staff members. Esther has her degree in Social Science from Wesley College.
Mr. Tzanis currently serves as the EVP, Head of R&D at Neuraptive Therapeutics. Mr. Tzanis brings over 25 years of global development experience in all aspects of drug development to the company. Prior to joining Neuraptive, Mr. Tzanis served as Chief Development Officer at Paratek Pharmaceuticals, where he led all development activities, including the successful approval of omadacycline (Nuzyra®) and sarecycline (Seysara®).
Prior to Paratek, Mr. Tzanis was Head of Development Operations and
Biometrics at Endo Pharmaceuticals, where he had leadership responsibility in clinical and project management. During his tenure with Endo Pharmaceuticals, Mr. Tzanis was responsible for several late-stage development programs, including BEMA® Buprenorphine (Belbuca). Prior to joining Endo Pharmaceuticals, Mr. Tzanis had roles of increasing responsibilities at Quintiles (now IQUVIA), Wyeth Pharmaceuticals, and Pfizer.
Over his 25 years of experience in the pharmaceutical industry, Mr. Tzanis has been involved in the regulatory approval of ten products among a variety of products designed to treat infectious diseases, dermatology, central nervous system disorders, including panic disorder, major depressive disorder, sleep, pain, as well as opioid-induced constipation and rheumatoid arthritis.